Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn

NCT06860399 | Completed Phase 1 DMC

• 2 other identifiers: UDMS-Pediatrics-2025-0120230501
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if drug Vardenafil works to treat pulmonary hypertension in newborns, It will also learn about the safety of Vardenafil. The main questions it aims to answer are: Does Vardenafil lower the pulmonary hypertension in newborns? What medical problems do participants have when taking Vardenafil? Researchers will compare drug Vardenafil to drug Sildenafil to see if drug Vardenafil works better to treat pulmonary hypertension. Participants will be divided into 2 groups , one group will take oral drug: Vardenafil and the other group will take oral drug: Sildenafil every day. Pulmonary hypertension will be measured daily until it returns to normal. Keep a diary of the symptoms and any complications

Conditions

PPHN

Keywords

PPHN; Sildenafil; Vardenafil

Outcome Measures

Primary Outcomes (2)

• Pulmonary Hypertension

  Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.

  Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)

• Pulmonary Resistance

  Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio

  Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)

Secondary Outcomes (2)

• Respiratory Distress

  Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4)

• Death

  From day 1 of treatment till discharge from NICU ( 3 days to 90 days)

Study Arms (2)

Vardenfil

EXPERIMENTAL

Oral Vardenafil given q12h.

Drug: Vardenafil

Sildenafil

ACTIVE COMPARATOR

Oral Sildenafil given q6h.

Drug: Sildenafil

Interventions

Vardenafil DRUG

Oral Vardenafil

Also known as: fast fix

Vardenfil

Sildenafil DRUG

Oral Sildenafil

Also known as: viagra

Sildenafil

Eligibility Criteria

• Age: 24 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestation age: 28 weeks or more

You may not qualify if:

• Cardiac deformity, inability to administer the drug orally

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Children's Hospital

Damascus, 011, Syria

Location

MeSH Terms

Interventions

Vardenafil Dihydrochloride; Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• prof. Srour

  Children's Hospital Damascus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: May 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When summary data are published
• Access Criteria: researchers working on the same topic interested in conducting the same study in different conditions or comparing the treatment to a different drug can contact the researcher by email

Locations

SY (1)